U.S., Dec. 27 -- ClinicalTrials.gov registry received information related to the study (NCT07304531) titled 'First To Know Pregnancy Test - Clinical Evaluation Protocol' on Dec. 01.
Brief Summary: This study is evaluating the ADEXUSDx(R) hCG CLIA moderately complex, FDA-cleared test for potential over the counter (OTC) use and marketing as the First To Know(R) (FTK) Pregnancy test. The investigational FTK Pregnancy test will be used to assess its clinical performance in the intended use population (i.e., lay users) through self-testing in a simulated home setting.
Study Start Date: Oct. 14
Study Type: OBSERVATIONAL
Condition:
Pregnancy Detection
Intervention:
DEVICE: Diagnostic Test
For this observational trial , the Intervention of...